19 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Recall
Terminated
·Product code GKR·February 8, 2018
Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code OCX·February 17, 2015
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
FDA Recall
Terminated
·Cardinal Health·Product code LRO·October 3, 2005
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code LKF·July 3, 2014
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code LKF·May 18, 2015
ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code LKF·May 12, 2008
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code LKF·October 31, 2012
ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code LKF·May 12, 2008
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code GKF·May 24, 2005
CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NKF·April 4, 2003
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code LKF·May 13, 2014
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code LKF·May 30, 2019
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code LKF·October 31, 2012
Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.
FDA Recall
Terminated
·Catheter Research, Inc·Product code LKF·April 24, 2006